Spots Global Cancer Trial Database for Safety and Efficacy of Trans Sodium Crocetinate (TSC) With Radiation and Temozolomide in Newly Diagnosed Glioblastoma
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Trial Identification
Brief Title: Safety and Efficacy of Trans Sodium Crocetinate (TSC) With Radiation and Temozolomide in Newly Diagnosed Glioblastoma
Official Title: Open-label Phase 1/2 (Safety Lead-in) Study of Trans Sodium Crocetinate (TSC) With Concomitant Treatment of Fractionated Radiation Therapy and Temozolomide in Newly Diagnosed Glioblastoma (GBM) Patients to Evaluate Safety and Efficacy
Study ID: NCT01465347
Interventions
Study Description
Brief Summary: This open-label study evaluated the safety and efficacy of TSC when dosed concomitantly with the standard of care (radiation therapy and temozolomide) for newly diagnosed glioblastoma in adults. All patients received TSC in the study. The objective of the study was to evaluate the effect of TSC on survival and tumor response in patients with GBM while establishing an acceptable patient risk profile.
Detailed Description: The overall objectives of this Phase 1/2 clinical study in newly diagnosed GBM patients was to evaluate the safety and tolerability, efficacy, PK profile, PFS/time to disease progression, QoL, and overall survival in adults when TSC is added to the standard of care regimen of radiation therapy and temozolomide. All patients received TSC in this study. The primary objective of the Phase 1 portion of the study was to evaluate the safety (DLT rate) and to define the dosing regimen of TSC for the larger Phase 2 study. The primary clinical endpoint was overall survival at 24 months and patients will be followed for up to 3 years.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
St. Joseph's Medical Center Barrow Neurology Clinics, Phoenix, Arizona, United States
University of Arkansas Winthrop P. Rockefeller Cancer Institute, Little Rock, Arkansas, United States
USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States
Cedars-Sinai Medical Center, Los Angeles, California, United States
The George Washington University Medical Center, Washington, D.C., District of Columbia, United States
University of Florida McKnight Brain Institute, Gainesville, Florida, United States
Emory University Winship Cancer Institute, Atlanta, Georgia, United States
Northwestern University Robert H. Lurie Comprehensive Cancer Center, Chicago, Illinois, United States
Rush University Medical Center, Chicago, Illinois, United States
University of Kentucky Markey Cancer Center, Lexington, Kentucky, United States
North Shore University Hospital, Manhasset, New York, United States
Forsyth Regional Cancer Center, Winston-Salem, North Carolina, United States
Penn State University Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Baylor University Medical Center, Dallas, Texas, United States
University of Texas Health Science Center Memorial Hermann Medical Center, Houston, Texas, United States
UVA Health Sciences Center Emily Couric Clinical Cancer Center, Charlottesville, Virginia, United States
Froedtert & Medical College of Wisconsin Cancer Center, Milwaukee, Wisconsin, United States
Contact Details
Name: David R. Jones, M.D.
Affiliation: Diffusion Pharmaceuticals Inc
Role: STUDY_CHAIR
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